CompletedPhase 3

Transdermal Clonidine in the Treatment of Severe Hyperemesis Gravidarum

Italy13 participantsStarted 2012-02

Plain-language summary

CLONEMESI is an academic, independent, randomized placebo-controlled trial to assess the effect of transdermal (TD) clonidine in improving the symptoms of severe Hyperemesis Gravidarum(HG) affecting women in their 6th-12th week of pregnancy. The study has a crossover design.

Who can participate

SexFEMALE

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Inclusion Criteria: * Gestational age 6-12 weeks and a major grade of HG clinical severity defined as follows: * a PUQE score index ≥ 13 associated to one or more of the following conditions: * weight loss \> 5% of pregravidic weight, * electrolyte disturbances, * dehydration, * duration of symptoms \> 10 days , * inadequate food and drink intake Exclusion Criteria: * Language barrier.

What they're measuring

PUQE Score for Assessment of Severity in Hyperemesis Gravidarum

Timeframe: Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.

VAS Score for Assessment of Severity in Hyperemesis Gravidarum

Timeframe: Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.

Trial details

NCT IDNCT01559012

SponsorA.O.U. Città della Salute e della Scienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2014-02-12

View on ClinicalTrials.gov More Hyperemesis Gravidarum trials